Senior Director, GCP Quality Oversight

Bicara Therapeutics; Boston (MA); Hybrid; USD 150,000 - 180,000; Full time

Job summary

A biopharmaceutical company in Boston is seeking a Senior Director for GCP Quality Oversight. This pivotal role involves managing GCP activities for clinical trials, ensuring compliance with regulations and best practices. Candidates must possess a Bachelor's degree and at least 10 years of quality assurance experience within the pharmaceutical industry. Strong skills in audits and cross-functional collaboration are essential. This role offers a hybrid work schedule with flexible office attendance.

Qualifications

• 10+ years of experience in quality assurance in the pharmaceutical/biotech industry.
• Subject matter expert in GCP guidelines and FDA regulations.
• Certification in quality assurance (e.g., Certified Quality Auditor) is desirable.

Responsibilities

• Oversee compliance of clinical trial activities with GCP guidelines.
• Conduct reviews of study-related documentation.
• Plan and participate in internal audits and external inspections.
• Develop internal training programs on GCP regulations.
• Collaborate to identify and mitigate GCP compliance risks.

Skills

Quality Assurance

GCP Compliance

Audit Planning

Cross-Functional Collaboration

Risk Mitigation

Problem Solving

Education

Bachelor's degree in life sciences, pharmacy, or nursing

Job description

Senior Director, GCP Quality Oversight at Bicara Therapeutics

Position Overview

The Senior Director, GCP Quality Oversight candidate will manage activities related to the development, maintenance and oversight of GCP activities for clinical trials sponsored by the company. Responsibilities include ensuring quality and compliance of company-sponsored clinical trials with SOPs, regulatory requirements (US FDA, ICH, EU and country specific), and industry standards.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• Ensure all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH‑GCP), and applicable laws.
• Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
• Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
• Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders.
• Collaborate with cross‑functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies.
• Maintain and enhance Bicara Therapeutics’ QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
• Investigate deviations, non‑compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
• Evaluate and monitor the performance of third‑party vendors, including contract research organizations (CROs), to ensure compliance with GCP requirements.
• Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP‑related processes and procedures.

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
• Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
• Subject matter expert in GCP guidelines, ICH‑GCP, FDA regulations, and other relevant regulatory requirements.
• Experience conducting GCP audits, inspections, and vendor qualifications/assessments.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
• Detail‑oriented mindset with a proactive approach to problem‑solving and decision‑making.
• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.

Company Overview

Bicara Therapeutics is a clinical‑stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds human transforming growth factor beta (TGF‑β). This dual‑targeting mechanism may provide potent anti‑tumor activity by blocking both EGFR survival and proliferation and TGF‑β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma and other solid tumor types.

For more information, visit www.bicara.com or follow us on LinkedIn or X.

EEO Statement

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.